Patient-reported outcomes for patients with metastatic castration-resistant prostate cancer receiving docetaxel and atrasentan versus docetaxel and placebo in a randomized phase iii clinical trial (Swog s0421)

Joseph M. Unger, Katherine Griffin, Gary W. Donaldson, Karen M. Baranowski, Margorie J. Good, Eunicia Reburiano, Maha Hussain, Paul J. Monk, Peter J. Van Veldhuizen, Michael A. Carducci, Celestia S. Higano, Primo N. Lara, Catherine M. Tangen, David I. Quinn, James L. Wade, Nicholas J. Vogelzang, Ian M. Thompson, Carol M. Moinpour

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background: SWOG S0421 was a large randomized trial comparing docetaxel/prednisone plus placebo (DPP) to docetaxel/prednisone plus atrasentan over 12 cycles for patients with metastatic castration-resistant prostate cancer (mCRPC). The current report presents the PRO results for this trial, an important secondary endpoint. Methods: The trial specified two primary PRO endpoints. Palliation of worst pain was based on the Brief Pain Inventory (BPI), where a 2 point difference is defined as clinically meaningful. Improvement of functional status was based on the Functional Assessment of Cancer Therapy – Prostate Cancer Trial Outcome Index (FACT-P TOI); a 5-point difference has been defined as clinically meaningful. We compared rates by arm using chi-square tests. Longitudinal analyses using linear mixed models addressed changes by arm over time. Results: Four-hundred eighty-nine patients on each arm were evaluable for PRO endpoint data. There were no differences by arm in clinically meaningful pain palliation (41.7% for DPP vs. 44.0% for DPA, p =.70) or functional status (24.2% for DPP vs. 28.7% for DPA, p =.13). Longitudinal comparisons indicated no differences over time by arm for BPI Worst Pain scores (0.13 points, p =.23). Patients on the DPA arm had improved functional status of 1.78 points on average, a statistically significant (p =.02) but not clinically meaningful difference. Conclusions: The SWOG S0421 PRO data showed little evidence of clinically meaningful differences by arm in either pain palliation or functional status.

Original languageEnglish (US)
Article number27
JournalJournal of Patient-Reported Outcomes
Volume2
DOIs
StatePublished - Jan 1 2018

Keywords

  • Cancer clinical trial
  • Functional status
  • Health-related quality of life (HRQL)
  • Metastatic castration-resistant prostate Cancer (mCRPC)
  • Pain
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Health Informatics
  • Health Information Management

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